Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane … (NCT06379685) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface.
32 participantsStarted 2025-12-30
Plain-language summary
This is a phase I clinical study to evaluate the safety and tolerability of PRO-190 ophthalmic solution through the incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, changes in the ocular comfort index (OCI) score, and IOP measurement compared to Systane Ultra®.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Having the ability to voluntarily give their signed informed consent.
* Clinically healthy subjects.
* Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.
* Age ≥ 18 years.
* No history of contact lens wear
* Women of childbearing potential who have not undergone Bilateral Tubal Occlusion (BTO \[Tubal Ligation\]), hysterectomy, or bilateral oophorectomy must ensure continuation (initiated ≥ 30 days prior to signing the ied consent form \[ICF\]) of the use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
* Having vital signs within normal parameters.
* Best corrected visual acuity (BCVA) of 20/30 or better in both eyes.
* Having an intraocular pressure ≥ 10 and ≤ 21 mmHg.
Exclusion Criteria:
* History of hypersensitivity to any of the components of the drugs under investigation.
* Use of ophthalmic medications from any pharmacological group.
* Use of medications by any other route of administration.
* In the case of women: being pregnant, breastfeeding, or planning to become pregnant within the study period.
* Having participated in any clinical research study 30 days prior to inclusion in this study.
* Having previously participated in this same study.
* History of any chronic-degenerative disease, including Diabetes Mellitus or Systemic Arterial Hypertension.
* Diagnosis of glaucoma or ocular hypertension.
* Known diagnosis of liver or heart disease.
* Presenti…
What they're measuring
1
Incidence Unexpected Related Adverse Reactions
Timeframe: Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), 8 (Final Visit) and 12 (Safety Call) after the inclusion of each subject.